Smart Manufacturing Systems Designer

Scorpion Therapeutics; Marietta (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking a qualified engineer to develop, test, and document electronic batch records (eBR) in the Siemens OpCenter platform within project timelines. You will gather production requirements, design eBR workflows, and ensure they align with GMP and EHS standards.

Responsibilities include testing, training, and creating validation protocols; connecting eBR to OSI-PI and SAP; and maintaining master data and SOP documentation while driving process improvements on the shop

Qualifications

• Bachelor's degree in engineering, computer science, information systems, or related technical discipline.
• 3+ years’ experience in a manufacturing environment.
• 2+ years’ experience with MES design, eBR development, or similar digital manufacturing tools.
• Experience creating process documentation, flowcharts, or Visio diagrams.
• Experience with testing and validation in a regulated environment.
• Hands-on experience with Siemens OpCenter (or another MES platform).

Responsibilities

• Engage process owners and stakeholders to acquire relevant process information for eBR design.
• Design and create/update business process documentation for eBR to support MES implementations and the eBR lifecycle.
• Convert business process documentation into eBR in MES.
• Create testing and validation documentation to ensure functional and user requirements are met.
• Test and validate eBR and associated protocols to align with existing manufacturing processes.
• Connect eBR to external systems (e.g., OSI-PI, SAP) to pull data into eBR.
• Support and train end-users on eBR use, troubleshoot issues, and support exception management (e.g., data correction).
• Drive continuous improvement using MES data and shopfloor Gemba Walks; identify and share best practices.
• Create documentation for LSOP creation and training materials.
• Compile and maintain relevant SAP and MES master data.
• Perform responsibilities in compliance with applicable EHS and GMP regulations and SOPs.

Skills

Business Analysis

Stakeholder Management

Data Validation

Decision Making

Education

Bachelor’s degree in engineering / CS / information systems

Tools

Siemens OpCenter

OSI-PI

SAP

Visio

APIs

Scripting

Job description

Position Summary

The purpose of the role is to be primarily responsible for the development, creation, update, and testing of electronic batch records (eBR) in the Siemens OpCenter platform within the agreed timeline. The role elicits and gathers user requirements from the production team and converts them into an executable eBR. The role is also responsible for testing, training, and documentation associated with creation and revision of the eBR.

Responsibilities

• Engage process owners and stakeholders to acquire relevant process information for eBR design.
• Design and create/update business process documentation for eBR to support MES implementations and the eBR lifecycle.
• Convert business process documentation into eBR in MES.
• Create testing and validation documentation to ensure functional and user requirements are met.
• Test and validate eBR and associated protocols to align with existing manufacturing processes.
• Connect eBR to external systems (e.g., OSI-PI, SAP) to pull data into eBR.
• Support and train end-users on eBR use, troubleshoot issues, and support exception management (e.g., data correction).
• Drive continuous improvement using MES data and shopfloor Gemba Walks; identify and share best practices.
• Create documentation for LSOP creation and training materials.
• Compile and maintain relevant SAP and MES master data.
• Perform responsibilities in compliance with applicable EHS and GMP regulations and SOPs.

Basic Qualifications (Required)

• Bachelor’s degree in engineering, computer science, information systems, or related technical discipline (or equivalent experience).
• 3+ years’ experience in a manufacturing environment.
• 2+ years’ experience with MES design, eBR development, or similar digital manufacturing tools.
• Experience creating process documentation, flowcharts, or Visio diagrams.
• Experience with testing and validation in a regulated environment.
• Hands-on experience with Siemens OpCenter (or another MES platform).

Preferred Qualifications

• Experience in pharmaceutical or biotech manufacturing.
• Familiarity with OSI-PI, SAP, APIs; basic scripting/coding.
• Experience with GMP documentation, validation protocols, and compliance activities.
• Customer-focused, organized, able to work independently in a matrix environment.
• Strong written/verbal communication and cross-functional teamwork.

Skills

Business Analysis; Business Requirements Analysis; Data Validation; Decision Making; Project Scoping; Stakeholder Management